Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of iota-carrageenan eye drops (ncx-4240)

Conditions: Adenoviral Conjunctivitis

Summary: this clinical investigation aims at demonstrating that ncx-4240 is effective and safe in decreasing the number of days where adenoviral conjunctivis is detected in the eye and in reducing the duration and/or the severity of the signs and symptoms of adenoviral conjunctivis

a multicenter, double masked, parallel, randomized 1:1 ratio clinical investigation comparing carrageenan eye drops (ncx 4240) versus placebo up to 21 days. total expected number of patients: 148 randomization: patients will be randomized 1:1 between: * group a: eye drops containing iota-carrageenan (ncx 4240), 1 drop in each eye 8 times/day for 7 days (mandatory) then at least 4 to 8 times/day for the next 14 days until day 21 or * group b: ocular lubricant eye drop (carmellose 0.5% sterile solution) 1 drop in each eye 8 times/day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until day 21.

Eligibility criteria:
inclusion criteria: * with uni-or bilateral acute adenoviral conjunctivis as diagnostised with adenoplus test * conjunctivis signs and symptoms in at least one eye and positive adenoplus test in at least one eye whatever signs/symptoms and positive adenoplus test are from the same eye or not exclusion criteria: * negative results with adenoplus test in both eyes * a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation

Keywords: adenoviral conjunctivis iota-carrageenan
study of allogenic adipose-derived stem cells in crohn's fistula

Conditions: Crohn

Summary: adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ascs) show also low immunogenicity. anterogen has developed antg-asc(autologous asc) which has shown good efficacy and safety in phase i and ii study on the patients with crohn's fistula. however, crohn's patients are sometimes not fat enough to extract fat tissue for culturing ascs. therefore the investigators have planned to study allogenic ascs for safety and efficacy in patients with crohn's fistula.


Eligibility criteria:
inclusion criteria: * diagnosed with crohn's disease * crohn's fistula which has been lasted at least for 3 months * negative for beta-hcg pregnancy test exclusion criteria: * medical history with variant creutzfeldt jacobs disease * allergic to anesthetics or bovine protein or fibrin glue * autoimmune disease other than crohn's disease * infectious disease * sepsis or active tuberculosis * pregnant or breast feeding woman * inflammatory bowel disease other than crohn's disease * active crohn's disease with cdai score \> 200 * malignant tumor * fistula's diameter \> 2 cm

Keywords: crohn's fistula
effect of simultaneous cystectomy on ovarian reserve in cases of adnexal detorsion

Conditions: Ovarian Torsion

Summary: there are mostly ovarian cysts under adnexal torsion from gynecological emergencies. there are many studies in the literature examining the effect of adnexal detorsion on ovarian reserve. however, there is no study in the literature examining the effect of concomitant cystectomy. in this study, the investigators aimed to investigate whether the cystectomy procedure performed together with detorsion has an additional effect on the ovarian reserve in cases of ovarian torsion with cysts.

all women who underwent emergency surgery in the investigators' obstetrics and gynecology department since april 2015 due to adnexal torsion were analyzed. all patients who underwent ovarian detorsion (group 1) and ovarian detorsion+cystectomy (group 2) were called for control between 6-12 months postoperatively. in all patients, the sizes of both ovaries and the number of antral follicles were counted by ultrasonography by 2 physicians who did not know the detorsion side beforehand. all women will be compared within and between groups in terms of ovarian sizes and antral follicle numbers.

Eligibility criteria:
inclusion criteria: * all women who underwent emergency surgery for ovarian torsion exclusion criteria: * those who underwent oophorectomy with suspicion of malignancy * when faced with spontaneously amputated ovary due to chronic or acute torsion * women with only salpinx torsion

Keywords: ovarian torsion cystectomy ovarian reserve
efficacy and safety of v0111 cream on open cracked heel in diabetic patients with polyneuropathy.

Conditions: Open Cracked Heel in Diabetic Patients With Polyneuropathy

Summary: the purpose of this study is to evaluate the efficacy and the safety of the cream v0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.


Eligibility criteria:
inclusion criteria: * diabetes mellitus with neuropathy, * cracked open heel with at least one fissure grade 2, exclusion criteria: * open wound, skin infection, haemorrhagic crack on feet, * major static disorder , * ulceration and history of ulceration, * active haemorrhagic crack, * hyperkeratotic disease * diabetic arteriopathy,

Keywords: diabetic neuropathies diabetes mellitus diabetic foot diabetes complications
a study of npx267 for subjects with solid tumors known to express hhla2/b7-h7

Conditions: Metastatic Malignant Neoplasm

Summary: npx267 is an antibody drug targeting the inhibitory receptor for b7-h7 (hhla2) which may control evasion of the immune response in tumors. the goal of this clinical trial is to learn whether npx267 is safe and tolerable in patients whose cancers are known to express hhla2 including epidermal growth factor receptor (egfr) mutant non-small cell lung cancer. the main questions it aims to answer are: * what is an appropriate dose to be given to patients? * are the side effects of treatment manageable? participants will be evaluated for participation in the study. patients who are treated will receive an intravenous infusion of npx267 every three weeks if their disease has not progressed. patients will be closely monitored by the treating physician.

this trial is divided into two parts. the first part (dose escalation) will test different doses of drug to find a dose for part two. in the second part (dose expansion), more patients will be tested to see if the drug has an effect on patient's tumors. throughout the study, data will be collected to characterize the clinical activity of the drug. samples of blood will be taken to help in an understanding of how the drug behaves in the body by assessing the amount of drug in the blood over time (pharmacokinetics), and changes in blood components (pharmacodynamics and safety). tumor imaging by computed tomography (ct) or magnetic resonance imaging (mri) will be done about every nine weeks to assess npx267 impact on tumor growth.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to standard of care therapy in one of the following indications: part 1a: non-small cell lung carcinoma (nsclc), renal cell carcinoma (rcc), colorectal carcinoma (crc), cholangiocarcinoma (cca), pancreatic cancer (pdac), urothelial carcinoma (ucc), gastric/gastroesophageal carcinoma, triple negative breast carcinoma, endometrial carcinoma, cervical cancer, osteosarcoma, and prostate cancer * eastern cooperative oncology group (ecog) performance status 0 or 1 * normal bone marrow, kidney and liver function * willing to use highly effective contraceptive measures throughout the trial exclusion criteria: * have any unresolved toxicity of grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy \> 6 months, or changes in skin pigmentation * have known or suspected brain metastases, unless they are clinically stable * known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily * history of grade 3 immune-related pneumonitis or colitis

Keywords: b7-h7/hhla2 non-small cell lung carcinoma renal cell carcinoma colorectal carcinoma cholangiocarcinoma pancreatic cancer urothelial carcinoma gastric gastroesophageal carcinoma triple negative breast carcinoma endometrial carcinoma cervical cancer osteosarcoma prostate cancer recist dose escalation dose expansion
the effect of laughter yoga on premenstrual symptoms and quality of life in midwifery students

Conditions: Premenstrual Syndrome; Quality of Life

Summary: the research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (pms) and quality of life. research hypotheses h0: online laughter yoga has no effect on premenstrual symptoms. h1: online laughter yoga has an effect on premenstrual symptoms. h0: online laughter yoga has no effect on quality of life. h1: online laughter yoga has an impact on quality of life.

59 midwifery students will participate in the research. in this study, the number of laughter yoga sessions was determined in line with the studies in the literature. each laughter yoga session is planned to last approximately 40-45 minutes. each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.

Eligibility criteria:
inclusion criteria: * to agree to participate in the research, * to be over 18 years old, * not having taken vocational courses * not having a chronic disease, * having a regular menstrual period, * having at least 110 points on the pms scale * not receiving medical treatment for pms. exclusion criteria: * refusing to participate in the research, * to have taken vocational courses, * having a chronic illness * getting a score lower than 110 on the pms scale, * having any condition where laughter yoga should be avoided (having had abdominal surgery in the last three months, taking regular medications, epilepsy, uncontrollable hypertension, glaucoma, hernia, etc.) * receiving medical treatment for pms.

Keywords: premenstrual syndrome quality of life laughter yoga laughter therapy student
intercostal cryoanalgesia for chronic pain after vats lung resection

Conditions: Cryotherapy Effect; Chronic Pain; Lung Cancer; Surgery

Summary: intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. the aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the prevention of chronic thoracic pain after vats lung resection surgery.

vats lung resection is associated with a high incidence of persistent thoracic pain. to our knowledge, there is no study on the effect of cryoanalgesia on the incidence and severity of chronic thoracic pain 3 months after vats lung resection. intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. in a recent study by ilfeld \& al, intercostal cryoanalgesia (combined with a single-injection paravertebral block) was able to drastically lower the incidence of chronic pain after total mastectomy compared to the use of the paravertebral block alone (3% vs 17%). the aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia for the prevention of chronic thoracic pain after vats lung resection surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by vats for lung cancer * american society of anesthesiologists (asa) score 1-3 exclusion criteria: * contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space) * contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia) * epidural analgesia preferred (high risk of thoracotomy, marginal lung function) * surgical criteria (conversion to thoracotomy, non anatomical wedge resection) * preoperative thoracic or shoulder pain on the operated side * known allergy to acetaminophen, celecoxib, sulfa, or both hydromorphone and morphine * history of thoracic surgery on the operated site * regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine) * inability to understand pain scales or to communicate clearly despite adequate teaching * contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate \< 60 ml/min, active gastric ulcer) * pregnancy * patient refusal to participate
heliox on the work of breathing in adult patients with lower airway stenosis

Conditions: Airway Obstruction

Summary: heliox (a mixture of helium and oxygen) can reduce the work of breathing in patients with airway stenosis by modifying turbulent flow into laminar flow. the aim of this study was to analyze the effect of heliox versus conventional oxygen therapy in patients with lower airway stenosis on muscular effort measured by electromyography and diaphragmatic ultrasound, thoracoabdominal synchrony assessed with plethysmographic bands, dyspnea, stridor, oxygen saturation, transcutaneous carbon dioxide value, blood pressure, heart rate and respiratory rate.

lower airway stenosis results in increased work of breathing with stridor and dyspnea, as a consequence of the increased resistances caused by the reduction in airway diameter. airway resistance also depends on the length of the airway and the type of gas flow. heliox (a mixture of helium and oxygen) is a gas less dense than air, which can change the flow from turbulent to laminar, reducing airway resistance by 20 to 40%, and therefore decreasing the work of breathing. heliox is an inert gas that does not react with biological membranes, so there are few complications associated with its use, the most relevant being hypoxemia when fixed mixtures are not used and the the fraction of inspired oxygen (fio2) supplied is less than 21%. the aim of the study was to evaluate if during the perioperative period of lower airway stenosis the administration of heliox compared to oxygen could reduce the work of breathing and improve dyspnea. for this purpose, patients were treated for 30 minutes with heliox (fixed mixture of 70% helium and 30% oxygen) using a non rebreather mask or reservoir bag versus 30 minutes with oxygen 31% using a venturi mask.

Eligibility criteria:
inclusion criteria: * patients with lower airway stenosis evaluated at the respiratory endoscopy unit of the hospital universitario 12 de octubre on the waiting list for endoscopic intervention on stenosis. * stenosis grade ≥ 3 and borg scale score \> 2. exclusion criteria: * presence of relevant comorbidities (uncontrolled ischemic heart disease, ventricular dysfunction, pneumopathies with severe respiratory insufficiency, severe pulmonary hypertension). * inability to perform the test due to severe dyspnea or need for emergency intervention. * patient on continuous mechanical ventilation, invasive or non-invasive.

Keywords: heliox airway stenosis work of breathing airway resistance
pilot study to detect monkey pox virus in sperm: poxsperm

Conditions: Monkeypox

Summary: given the current emerging epidemic of the monkeypox virus (mpxv) and its route of transmission, the main objective of this pilot study is to characterize the presence of the mpxv in the semen of patients in the acute phase of infection and following this infection.

since may 2022, a total of 16 000 new cases of monkey pox virus infection has been reported in 76 non-endemic countries. the who has declared this epidemic as a public health emergency. principal routes of transmission are direct skin or mucosa contact or aerosol transmission. the current epidemic mainly affects men having sexual relations with others men and men reporting having recent sexual relations with new or multiple partners. we may wonder if there is a risk of transmission during an intercourse. moreover, monkey pox virus infection in human testicle has not been studied yet. among viruses that infect human semen, some viruses can persist for several months or even years in the semen of cured men. in this context, we propose a research project about the pathophysiology of mpxv in the male genital tract by a clinical approach. men with a diagnosis of mpxv infection confirmed by a positive pcr and who agreed to be included as volunteer will go to cecos at paule de viguier hospital, purpan. each patient will take a semen and urine sample, have a blood sample and a saliva sample, and a skin sample in case of a lesion; the earliest after the confirmation of the diagnosis of the infection (before the 7th day, the days will be noted) then on day 15, day 30, day 60, day 90 and day 180.

Eligibility criteria:
inclusion criteria: * in the acute phase of mpxv infection and whose pcr reveals the viral genome in a skin sample or in any other sample. * able to travel to the laboratory for the samples * who gave his free and informed consent and having signed the consent * patient affiliated to a social security scheme or equivalent exclusion criteria: * patient who has previously consulted for male infertility or who has previously performed an abnormal semen test (who standard) * patient with ejaculation disorder or unable to collect semen or with abnormal semen volume (\<1.5 ml). * patient who presents serious clinical signs that do not allow him to travel to the investigation center. * patient under a protection regime (including guardianship, curatorship or safeguard of justice)

Keywords: monkeypox virus semen testicle acute phase and follow-up
comparison of clinical outcomes pod l gf vs pod f gf (phy1707)

Conditions: Cataract; Lens Opacity; Presbyopia

Summary: prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal iols differing in the dominance of additional power. the investigational device pod l gf shows dominance for the intermediate addition (+1.75 d), whereas the control device pod f gf shows dominance for the near addition (+3.5 d). implantation of the iols is bilaterally.

this is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. the patients will either be implanted with the hydrophobic iol finevision pod l gf or the hydrophobic iol finevision pod f gf (both lenses: (physiol, liège, belgium). the devices under investigation (finevision pod l gf and pod f gf) are trifocal glistening-free acrylic intraocular lenses (iols) manufactured by the sponsor of this study physiol sa/nv. both consist of the same hydrophobic material. the main difference between the lenses is the dominance of additional power. the investigational device pod l gf shows dominance for the intermediate addition (+1.75 d), whereas the control device pod f gf shows dominance for the near addition (+3.5 d). the iols will be implanted as part of the routine cataract surgery on patients suffering from cataract development. subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. subjects would have the option for unscheduled visits if required medically. primary and secondary endpoint data will be collected at the 6 months follow up visit. data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility criteria:
inclusion criteria: * cataractous eyes and/or patients suffering from presbyopia with no ocular comorbidity * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * age of patient \<40 years * irregular astigmatism * regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120° * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * amd suspicious eyes * complicated surgery

Keywords: intraocular lens trifocal cataract physiol
a non-interventional study (nis) registry for the epidemiological and scientific evaluation of epidermal growth factor receptor (egfr) mutation status in patients with newly diagnosed locally advanced or metastatic non small cell lung cancer (nsclc) (stage iiib/iv non-small cell lung cancer).

Conditions: Non Small Cell Lung Cancer

Summary: the primary objective of the study is to collect epidemiological data on egfr mutation status \[m+(mutation positive), m-(mutation negative)\] in a population of predominantly caucasian ethnicity, and to correlate egfr mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). in particular, the study will aim to determine the frequency of egfr m+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with egfr mutation positivity (i.e., smokers, men, and non-adenocarcinoma).


Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. female or male aged 18 years or above. 3. histologically confirmed locally advanced or metastatic nsclc (stage iiib/iv). 4. patients receiving 1st-line treatment for iiib/iv nsclc. 5. patients with known egfr mutation status (i.e. patients must be either egfr m+, egfr m- or egfr mx). 6. tumour not amenable to curative surgery or radiotherapy. exclusion criteria: 1. mixed histology of small cell and non-small cell lung cancer.

Keywords: non small cell lung cancer egfr mutations
standard oxytocin versus high dose oxytocin to control postpartum hemorrhage in high risk pregnancy during elective cesarean section

Conditions: Post Partum Hemorrhage

Summary: controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional use of uterotonics in the first 24 hours after cesarean section for high risk pregnancy.


Eligibility criteria:
inclusion criteria: * - medical disorders ie: hypertensive diseases with pregnancy - diabetes mellitus - collagen diseases - coagulopathies - cardiac diseases - anemia * history of postpartum hemorrhage * placental disorders ie: placenta previa * infertility and icsi * high parity * history of endometriosis * fetal disorders (iugr, iufd, preterm, congenital anomalies, oligohydramnios or polyhydramnios, macrosomia) * preterm labor on uterine relaxants * twins pregnancy * patients on antiplatelets and anticoagulants * uneventful antenatal care exclusion criteria: * - oxytocin allergy * normal uncomplicated pregnancy * emergency cesarean section * exhausted uterus due to trial of normal labor * couvelaire uterus